The Verily Study Watch is a device worn on the wrist that digitizes patient physiologic measurements and processes the raw data through algorithms both on the wrist worn device and additional processing when communicated to cloud based computing systems. The idea is that the Verily watch would be worn similar (or as!) a consumer device but allow certain types of medical device functionality to be enabled or utilized. This obviously has great implications and opportunities for general population health.
Traditionally an idea such as this would be considered unlikely to meet regulatory requirements for medical devices. However with the 21st Century Cures Act in the US and the new FDA Digital Health Unit, we are seeing a new approach emerging for device clearance for products in this space. The FDA Pre-Cert program promises to formalize this new approach that uses more of a “qualify the process, not necessarily the product”. It remains to be seen how this will ultimately manifest and how it will ultimately affect the quality of these medical devices.
I certainly hope that companies in the digital space will embrace software quality assurance activities and employ solid software safety risk management methods. IEC 80002-1 would be a great place to start. Designing in safety risk controls is easy when the software engineer is aware of the need and purpose of the control early in the project, or early in the release cycle. Adding safety handling infrastructure can be difficult to do later. Also a quick tour through our software related recalls library should produce a healthy bit of caution to not be overconfident with software functionality – bugs that cause an app to restart are one thing, but bugs that inaccurately report physiologic measurements can be deadly.